Statement That Should Be Included In Product Inserts For FDA Approved Drugs

This would be its package insert, says Bill Sardi.

PRECAUTIONARY STATEMENT: Drugs approved by the FDA are tested against biologically inactive placebo pills and may not be as safe as other existing drugs for the same condition.  Furthermore, drugs are approved by the FDA based on relatively short-term study data and their long-term safety may not be known till years later.  Drugs may induce safety events that prompt a boxed warning on the label, issuance of a safety communication or even withdrawal from the marketplace long after FDA approval.  Furthermore, while effectiveness of drugs may be given in relative numbers, such as a certain drug reduces a health risk like heart attack or stroke by one-third (33%), in hard numbers risk may be reduced from 3 in 100 to 2 in 100, or an absolute risk reduction of only 1 in 100 (1%).  However side effects are usually tabulated in absolute numbers.  For example the risk for skin rash may be 1 in 100; muscle pain 2 in 100, and headache requiring a doctor’s visit 1 in 100, for a total side effect rate of 4 in 100 while the drug only reduces risk for disease of 1 in 100.  So the total side effect rate may exceed the benefit rate.  Additionally, many drugs deplete essential nutrients, such as metformin that depletes vitamin B12; lisinopril depletes zinc; statin drugs that deplete coenzyme Q10; steroidal drugs and aspirin that deplete vitamin C; diuretics that deplete magnesium.  Information about drug depletion of essential nutrients is not included on the label and generally not provided in product inserts.  The known interaction of drugs with other medications and dietary supplements is also not usually included in product inserts. Finally, there may be no studies of the total combined effects of multiple drugs such as commonly prescribed for many patients, for example an ACE inhibitor, statin cholesterol-lowering drug, diuretic water pill, beta blocker and aspirin tablet.  

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